Occlutech ASD Occluder
Rx Only
The Occlutech ASD Occluder is intended for percutaneous transcatheter closure of ostium secundum-type atrial septal defects. It is a self-centering occluder containing double discs and waist and is designed without left atrial hub. The combined flexible wires produce a conformable1 device to facilitate a natural deployment position2.
Indication for Use and Area of Application
The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type ASD. Patients indicated for ASD closure have:
- echocardiographic evidence of ostium secundum-type ASD,
- clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ≥ 1.5 or RV enlargement).
Contraindications
The Occlutech ASD Occluder is contraindicated for the following:
- Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
- Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
- Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
- Any patient known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
- Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.
Warnings
- The Occlutech ASD Occluder must be implanted exclusively by physicians trained in its use and are experienced with interventional transcatheter ASD closure techniques.
- Physicians who implant the Occlutech ASD Occluder must be able to recognize, assess and manage procedure-associated emergencies. On-site cardiac surgical support with corresponding personnel must be available.
- The use of improperly size-matched devices could seriously affect hemodynamics and optimal results. Before using this device, physicians shall carefully review the hemodynamic parameters as well as sizing information printed on the labels of the Occlutech ASD Occluder and its accessories (OPP and Occlutech Delivery Set III (ODS III)). Physicians shall also review the sizing and compatibility chart in section 5.1 (Table 1: Device Sizes and Recommended Occlutech Delivery Sets) before starting a procedure. Careful consideration shall be given to ensure accurate size-matching of its accessories with the corresponding device (i.e., review of device labels and color-coding).
- Before using the Occlutech ASD Occluder, the physician shall carefully review section 9 (Implantation Procedure) including relevant instructions therein on connecting the Occlutech ASD Occluder to the OPP. If a secure connection between the Occlutech ASD Occluder and OPP is not verified as described, disconnection of the device from the pusher may occur and the Occlutech ASD Occluder may embolize causing a life-threatening situation.
- The Occlutech ASD Occluder should not be used with delivery sets other than those recommended in section 5.1 (Table 1: Device Sizes and Recommended Occlutech Delivery Sets).
- After deployment and release of the Occlutech ASD Occluder, complications such as device dislocation or embolization may occur as a result of erroneous positioning or sizing of the device. These complications can present a life-threatening situation to the patient.
- An embolized Occlutech ASD Occluder must be retrieved using a snare and a larger delivery sheath. An emergency kit for the retrieval of the Occlutech ASD Occluder must be available in the catheterization laboratory during the procedure.
- The Occlutech ASD Occluder should only be released from the OPP after the physician has confirmed that the device is positioned correctly. This should be determined by performing fluoroscopy and/or Transesophageal (TEE) or Intracardiac Echocardiography (ICE) to visualize the Occlutech ASD Occluder and to confirm that the device is positioned properly.
- While still connected to the OPP, the Occlutech ASD Occluder can be retrieved or re-positioned using the recommended ODS III.
- The Occlutech ASD Occluder must be used exclusively in accordance with this IFU and its implantation is to be carried out as described in this IFU.
- The physician shall inspect all packaging and labels of all devices before opening and follow the Instructions for Use. If the product box or sterile packaging is damaged in any manner, the Occlutech ASD Occluder shall be considered as unsterile and should not be used.
- The physician shall not use this device or any of its components if a seal appears to be broken (contents may not be sterile); if the label appears marked with text or symbols other than those on the label shown in this IFU or if the label is illegible, inappropriate, or absent.
- The physician shall not use this device or any of its components after the “use by” (expiration) date.
- The Occlutech ASD Occluder and OPP is intended for single use only and is not suitable for re-sterilization. As soon as the Occlutech ASD Occluder and OPP devices are removed from the sterile packaging and used, they are contaminated. Re-use or re-sterilization may compromise the structural integrity of the devices, lead to device failure, and result in patient injury, illness or death.
- If, after inspection by the physician, the Occlutech ASD Occluder appears damaged or does not appear to function properly, the device is not suitable for implantation.
- Patients with a rim < 5 mm from the aortic root may have a higher risk of erosion and if closed using a device, they will require closer follow up. Patients with rim sizes < 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein may have a higher risk of device embolization and it is best to avoid doing such cases.
- Patients should be advised to avoid strenuous physical activity for a period of at least 2 weeks after device implantation.
Precautions
- Patients with body weight ˂ 8 kg might be at higher risk.
- The use of a single Occlutech ASD Occluder to repair multiple ASDs might bear a risk of inadequate closure or residual shunts.
- Cryptogenic stroke caused by ASD related left circulatory embolism has not been clinically evaluated for the Occlutech ASD Occluder. The use of the Occlutech ASD Occluder has not been studied in patients with patent foramen ovale.
- Use standard interventional cardiac catheterization techniques to place the Occlutech ASD Occluder.
- Placement of the Occlutech ASD Occluder may impact future cardiac interventions, for example transseptal puncture and mitral valve repair.
- The Occlutech ASD Occluder contains nickel-titanium alloy, which is generally considered safe. Patients allergic to nickel and/or titanium and/or nickel/titanium-based materials may suffer an allergic reaction to this device. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty in breathing, or inflammation of the face or throat.
Occlutech |
Occlutech Delivery Set III |
Occlutech Pistol Pusher |
Ø |
Ø |
Ø |
Atrial Septal Defect |
37ASD06P |
98DS007 |
38PP125 |
6 |
16.5 |
12.5 |
5 < D ≤ 6 |
37ASD07P |
98DS007 |
38PP125 |
7.5 |
18 |
14 |
6 < D ≤ 7.5 |
37ASD09P |
98DS007 |
38PP125 |
9 |
20,5 |
16,5 |
7.5 < D ≤ 9 |
37ASD10P |
98DS007 |
38PP125 |
10.5 |
22 |
18 |
9 < D ≤ 10.5 |
37ASD12P |
98DS009 |
38PP165 (yellow) |
12 |
27 |
23 |
10.5 < D ≤ 12 |
37ASD13P |
98DS009 |
38PP165 (yellow) |
13.5 |
28.5 |
24.5 |
12 < D ≤ 13.5 |
37ASD15P |
98DS009 |
38PP165 (yellow) |
15 |
30 |
26 |
12 < D ≤ 15 |
37ASD16P |
98DS009 |
38PP165 (yellow) |
16.5 |
31.5 |
27.5 |
15 < D ≤ 16.5 |
37ASD18P |
98DS009 |
38PP165 (yellow) |
18 |
33 |
29 |
15 < D ≤ 18 |
37ASD19P |
98DS010 |
38PP165 |
19.5 |
34.5 |
30.5 |
16.5 < D ≤ 19.5 |
37ASD21P |
98DS011 |
38PP185 |
21 |
36 |
32 |
18 < D ≤ 21 |
37ASD24P |
98DS011 |
38PP185 |
24 |
39 |
35 |
21 < D ≤ 24 |
37ASD27P |
98DS012 |
38PP210 |
27 |
42 |
38 |
24 < D ≤ 27 |
37ASD30P |
98DS012 |
38PP210 |
30 |
45 |
41 |
27 < D ≤ 30 |
37ASD33P |
98DS012 |
38PP210 |
33 |
48 |
43 |
30 < D ≤ 33 |
Content references:
- Pedra CAC, Pedra SF, Costa RN, et al. Mid-Term Outcomes after Percutaneous Closure of the Secundum Atrial Septal Defect with the Figulla-Occlutech Device. Journal of Interventional Cardiology. 2016;29(2):208-215. doi: https://doi.org/10.1111/joic.12284
- Kenny D, Eicken A, Dähnert I, et al. A randomized, controlled, multi‐center trial of the efficacy and safety of the Occlutech Figulla Flex‐II Occluder compared to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects. Catheterization and Cardiovascular Interventions. 2018;93(2):316-321. doi: https://doi.org/10.1002/ccd.27899
